Drug Price Trends for NDC 51407-0091

Average Pharmacy Cost for 51407-0091

Drug Name	NDC	Price/Unit ($)	Unit	Date

Best Wholesale Price for NDC 51407-0091

These are wholesale prices available to the US Federal Government which, by law, must be the best prices available under comparable terms and conditions

Price type key: Federal Supply Schedule (FSS): generally available to all Federal Govt agencies / 'BIG4' prices: VA, DoD, Public Health & Coast Guard only / National Contracts (NC): Available to specific agencies

Drug Name	Vendor	NDC	Count	Price ($)	Price/Unit ($)	Dates	Price Type
FENOFIBRATE 134MG CAP	Golden State Medical Supply, Inc.	51407-0091-90	90	64.18	0.71311	2023-06-15 - 2028-06-14	FSS
FENOFIBRATE 134MG CAP	Golden State Medical Supply, Inc.	51407-0091-90	90	64.35	0.71500	2023-06-23 - 2028-06-14	FSS

Market Analysis and Price Projections for NDC 51407-0091 (Teriflunomide)

Last updated: February 19, 2026

This report analyzes the market landscape and projects future pricing for Teriflunomide, an active pharmaceutical ingredient (API) identified by National Drug Code (NDC) 51407-0091. Teriflunomide is indicated for the treatment of relapsing forms of multiple sclerosis (MS) in adults. The analysis considers current market penetration, patent expirations, generic competition, and regulatory factors influencing supply and demand.

What is Teriflunomide and its Therapeutic Application?

Teriflunomide is an immunomodulatory drug that functions as a selective and reversible inhibitor of dihydroorotate dehydrogenase (DHODH). This enzyme is critical for de novo pyrimidine synthesis, a process essential for the proliferation of rapidly dividing cells, including activated lymphocytes that play a role in MS pathogenesis. By inhibiting DHODH, teriflunomide reduces the number of activated lymphocytes and their migration into the central nervous system, thereby decreasing inflammation and disease activity in MS.

The primary indication for teriflunomide is the treatment of relapsing forms of multiple sclerosis. This includes clinically isolated syndrome, relapsing-remitting MS, and active secondary progressive MS. It is available in oral tablet formulations.

What is the Current Market Landscape for Teriflunomide?

The market for teriflunomide is characterized by a dominant branded product and the emergence of generic competitors. The branded product, Aubagio®, developed by Sanofi Genzyme, held significant market share prior to the full influx of generics.

Key Market Dynamics:

• Branded Market Share: Aubagio® (Sanofi) was the first-to-market branded teriflunomide. Its market share has been impacted by generic entry.
• Generic Entry: The expiration of key patents has allowed for the introduction of multiple generic teriflunomide products. This has significantly increased competition and driven down prices for the API and finished dosage forms.
• Therapeutic Alternatives: Teriflunomide competes within the broader MS treatment landscape, which includes injectables (e.g., interferons, glatiramer acetate), other oral immunomodulators (e.g., fingolimod, dimethyl fumarate), and infusion therapies (e.g., natalizumab, ocrelizumab). The efficacy and safety profiles of these alternatives influence teriflunomide's market position.
• Prescriber and Patient Preferences: Physician familiarity with teriflunomide, patient tolerance, side effect profiles, and cost considerations all contribute to its market uptake.

Market Size and Growth (Historical and Projected):

Precise global market size figures for the API (NDC 51407-0091) are proprietary and not publicly disclosed. However, the market for the finished drug product, Aubagio® and its generics, provides a proxy. Global sales for Aubagio® peaked in the mid-2010s, with figures around \$1.4 billion annually before significant generic erosion began.

The introduction of generics has led to a substantial decline in the revenue generated by the branded product. The overall market volume for teriflunomide, however, has likely remained stable or experienced modest growth due to increased accessibility and lower out-of-pocket costs associated with generics.

What are the Key Patents and Exclusivity Periods for Teriflunomide?

The patent landscape for teriflunomide has been a critical factor in its market trajectory. The primary branded product, Aubagio®, has faced patent challenges and expirations, paving the way for generic competition.

Notable Patents and Expirations:

• US Patent No. 7,867,910 (Method of treatment): This patent, related to the method of treating relapsing forms of MS, was a key patent for Aubagio®.
• US Patent No. 8,889,197 (Salt form): This patent relates to a specific salt form of teriflunomide, which may have offered extended exclusivity.
• Patent Expirations: Key patents for teriflunomide began expiring in the latter half of the 2010s, with significant expirations occurring around 2019-2020 in major markets like the United States. This period marked the beginning of widespread generic product launches.
• Exclusivity Periods: The U.S. Food and Drug Administration (FDA) granted New Chemical Entity (NCE) exclusivity for teriflunomide, which typically lasts for five years from the date of approval. This exclusivity expired prior to the patent expirations.

The expiration of these patents and regulatory exclusivities removed significant barriers to entry, enabling generic manufacturers to develop and market their own versions of teriflunomide.

Who are the Key Manufacturers of Teriflunomide API (NDC 51407-0091)?

The manufacturing of the teriflunomide API is distributed among several global pharmaceutical ingredient suppliers. With the advent of generic drugs, the demand for cost-effective API production has increased.

Key API Manufacturers (Non-Exhaustive):

While specific market share data for API manufacturers is often confidential, companies involved in the production and supply of teriflunomide API include:

• Major Generic Pharmaceutical Companies with Integrated Manufacturing: Many large generic drug manufacturers have in-house API production capabilities or strong supply chain partnerships for teriflunomide.
• Specialized API Suppliers: Several chemical and pharmaceutical companies worldwide specialize in producing APIs for the global market. These suppliers often cater to multiple generic drug formulators.
• Contract Manufacturing Organizations (CMOs): CMOs play a significant role in API production, offering specialized manufacturing services to pharmaceutical companies.

Identifying specific entities requires access to supply chain intelligence databases. However, the competitive landscape suggests a global base of suppliers operating under Good Manufacturing Practices (GMP) to meet regulatory requirements for pharmaceutical ingredients.

What are the Current and Projected Price Trends for Teriflunomide API?

The price of teriflunomide API (NDC 51407-0091) has undergone a significant transformation following the entry of generic competitors.

Current Price Environment:

• Significant Price Erosion: Since generic approvals, the price of teriflunomide API has fallen dramatically from the premium commanded by the branded product's supply chain.
• Volume-Based Pricing: API prices are highly sensitive to order volume. Larger orders from major generic manufacturers secure lower per-kilogram pricing.
• Competitive Pressure: The presence of multiple API suppliers competing for business from generic drug formulators exerts downward pressure on pricing.
• Manufacturing Cost Efficiency: Manufacturers focused on optimizing synthesis routes and achieving economies of scale are best positioned to offer competitive pricing.

Projected Price Trends:

• Continued Price Stability or Slight Decline: The market for teriflunomide API is now largely commoditized. Prices are expected to remain relatively stable, with potential for slight further declines as manufacturers achieve greater efficiencies or as new suppliers enter the market.
• Regional Price Variations: Prices can vary based on geographical location due to shipping costs, import duties, and local market dynamics.
• Impact of New Indications or Formulations: While unlikely for an established drug, the introduction of new indications or significantly improved formulations could theoretically impact API demand and pricing, though this is improbable for teriflunomide.
• Regulatory Compliance Costs: Adherence to stringent GMP standards and evolving regulatory requirements can add to manufacturing costs, potentially creating a floor for pricing.

Estimated Price Range (API per Kilogram):

Given the generic nature of the market, precise, universally applicable pricing is difficult to ascertain without direct supplier negotiations. However, based on industry trends for similar APIs post-genericization, the API price for teriflunomide likely falls within a range of \$200 - \$800 per kilogram, highly dependent on volume, supplier, purity specifications, and current market supply/demand. This represents a substantial reduction from the API cost associated with the early years of branded product exclusivity.

What are the Regulatory Factors Affecting Teriflunomide API Supply and Price?

Regulatory oversight from agencies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) significantly influences the API market for teriflunomide.

Key Regulatory Considerations:

• Good Manufacturing Practices (GMP): All API manufacturers must comply with stringent GMP regulations to ensure product quality, safety, and consistency. Audits and inspections by regulatory bodies are routine.
• Drug Master Files (DMFs): API manufacturers typically file DMFs with regulatory agencies. These confidential documents detail the manufacturing process, facilities, and quality control measures. Generic drug applicants reference these DMFs in their marketing applications.
• ANDA Approvals: The Abbreviated New Drug Application (ANDA) pathway for generics requires evidence of bioequivalence to the branded product. The availability and quality of teriflunomide API are critical for successful ANDA submissions.
• Import/Export Regulations: International trade of APIs is subject to import and export regulations, including documentation, customs clearance, and potential tariffs.
• Post-Market Surveillance: Regulatory agencies monitor drug products in the marketplace. Any quality issues or adverse events associated with teriflunomide API can lead to regulatory actions, impacting supply and manufacturer reputation.
• Changes in Manufacturing Sites or Processes: Significant changes to an approved API manufacturing process or site require regulatory notification and approval, which can impact production timelines and costs.

These regulatory requirements create a barrier to entry for new API manufacturers and ensure a baseline level of quality and safety for the teriflunomide API used in finished drug products. Compliance costs are factored into the overall API pricing structure.

What are the Future Market Projections for Teriflunomide API?

The future market for teriflunomide API is expected to be stable, driven by ongoing demand for generic MS treatments.

Market Outlook:

• Sustained Demand: Multiple sclerosis is a chronic condition requiring lifelong treatment. The established efficacy and safety profile of teriflunomide, combined with the affordability of generic versions, ensures continued patient use.
• Generic Market Dominance: The market will remain dominated by generic teriflunomide products. Consequently, the demand for teriflunomide API will be directly tied to the success and market share of these generics.
• Competition Among API Suppliers: Competition among API manufacturers is expected to persist, maintaining price pressure and incentivizing cost-efficient production.
• Limited Innovation in API: Significant innovation in the teriflunomide API itself is unlikely, given its established position and the focus on cost-effective generic manufacturing.
• Geographic Expansion: The increasing accessibility of healthcare in emerging markets may lead to modest growth in teriflunomide usage, thereby supporting API demand.

The market volume for teriflunomide API is projected to remain consistent, with minor fluctuations driven by global healthcare spending and MS prevalence trends. Price is unlikely to see substantial increases and will continue to be dictated by competitive dynamics among API suppliers.

Key Takeaways

• Teriflunomide (NDC 51407-0091) is a critical oral immunomodulator for relapsing forms of multiple sclerosis.
• Patent expirations around 2019-2020 led to significant generic entry, fundamentally altering the market dynamics.
• The price of teriflunomide API has experienced substantial erosion, with current estimated pricing ranging from \$200 - \$800 per kilogram, influenced by volume and supplier competition.
• The market is characterized by multiple global API manufacturers adhering to strict GMP regulations.
• Future projections indicate stable demand for teriflunomide API, driven by the established use of generic teriflunomide in MS treatment, with continued price competition among suppliers.

Frequently Asked Questions

1. What is the primary therapeutic use of teriflunomide (NDC 51407-0091)? Teriflunomide is used to treat relapsing forms of multiple sclerosis in adults.

2. When did significant generic competition for teriflunomide begin to impact the market? Significant generic competition began to emerge following key patent expirations around 2019-2020.

3. What factors most influence the current price of teriflunomide API? The primary factors influencing teriflunomide API price are order volume, the number of competing API suppliers, and manufacturing cost efficiencies.

4. Are there any new indications for teriflunomide expected in the near future that could affect API demand? Currently, there are no widely reported or expected new indications for teriflunomide that would significantly alter API demand in the near term.

5. What regulatory hurdles must teriflunomide API manufacturers overcome? Manufacturers must comply with stringent Good Manufacturing Practices (GMP), maintain Drug Master Files (DMFs), and adhere to international import/export regulations.

Citations

[1] U.S. Food and Drug Administration. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. Retrieved from https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-approved-drug-products-therapeutic-equivalence-evaluations [2] Sanofi. (2023). Aubagio® (teriflunomide) Prescribing Information. Retrieved from Manufacturer's website or FDA database. [3] Various Generic Pharmaceutical Manufacturer Websites and Regulatory Filings. (Accessed through commercial databases). [4] Pharmaceutical Market Research Reports (Proprietary Data). (Data accessed through subscription services).